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Efficacy and Safety of Qishen Yiqi Dropping Pills in Patients With Severe Pulmonary Hypertension

NCT07604805 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-05-22

No results posted yet for this study

Summary

This study aims to compare the effectiveness and safety of two treatment approaches for patients with severe pulmonary hypertension: standard targeted drug therapy alone, and a combination of standard targeted drugs plus Qishen Yiqi Dropping Pills over 52 weeks of treatment.

Pulmonary hypertension is a chronic condition that raises blood pressure in the lung arteries, causing symptoms like shortness of breath, tiredness, and difficulty with physical activity. While targeted drug treatments are available, many patients still experience persistent symptoms and reduced quality of life. This study will enroll patients with severe pulmonary hypertension to see if adding Qishen Yiqi Dropping Pills to standard treatment can improve patient outcomes.

Participants will be randomly assigned to one of two groups: the combination treatment group will receive Qishen Yiqi Dropping Pills plus standard targeted drugs, and the control group will receive standard targeted drugs alone. All participants will be followed for 52 weeks, during which we will regularly assess:

* Changes in daily quality of life
* How far participants can walk in 6 minutes, and their level of breathlessness after the walk
* Changes in heart function and related blood test indicators
* Any side effects or discomfort during treatment The primary goal of this study is to see if the combination treatment can improve patients' exercise capacity and quality of life more effectively than standard treatment alone. We will also monitor the safety of adding Qishen Yiqi Dropping Pills to standard therapy. All study procedures follow ethical regulations, and participants can withdraw from the study at any time without affecting their regular medical care.

Conditions

  • Idiopathic Pulmonary Hypertension

Interventions

DRUG

Qishen Yiqi Dropping Pills 0.5g Oral Three Times Daily + Targeted Therapy for Pulmonary Arterial Hypertension

Experimental Group: Qishen Yiqi Dropping Pills combined with standard PAH-targeted therapy. Qishen Yiqi Dropping Pills is an NMPA-approved Chinese patent medicine for cardiovascular diseases, each pill is 0.5g, main ingredients include astragalus membranaceus, salvia miltiorrhiza, panax notoginseng and dalbergia odorifera. Administration: 0.5g orally tid after meals. Targeted therapy follows \*2021 Chinese PAH Diagnosis and Treatment Guidelines\*, including one or more approved PAH-targeted agents at clinically recommended doses. Total treatment duration: 26weeks.

DRUG

Standard Pulmonary Arterial Hypertension (PAH)-Targeted Therapy Alone

Control Group Intervention: Participants in this group receive standard pulmonary arterial hypertension (PAH)-targeted therapy alone, without additional Qishen Yiqi Dropping Pills. The targeted therapy regimen complies with the \*2021 Chinese Guidelines for the Diagnosis and Treatment of Pulmonary Hypertension\*, including one or more clinically approved PAH-targeted agents (endothelin receptor antagonists, phosphodiesterase type 5 inhibitors, or soluble guanylate cyclase stimulators) at standard recommended doses. The regimen is consistent with the participants' stable pre-enrollment treatment plan, or initiated per the protocol-specified dosing schedule, with no dose adjustment allowed during the study period unless required for safety reasons. The total treatment duration is 26 weeks, identical to the experimental group.

Sponsors & Collaborators

  • Guangdong Provincial People's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-25
Primary Completion
2030-06-30
Completion
2030-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07604805 on ClinicalTrials.gov